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Journal of Evaluation in Clinical Practice ISSN 1365-2753

Factors affecting the implementation process of clinical pathways: a mixed method study within the context of Swedish intensive care Petronella Bjurling-Sjöberg CCRN MSc,1,5 Barbro Wadensten RN PhD,2 Ulrika Pöder CCRN PhD,3 Lena Nordgren RN PhD4,6,7 and Inger Jansson RN PhD8 1 PhD Student, 2Associate Professor and Senior Lecturer, 3Senior Lecturer, 4Associate Researcher, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden 5 PhD Student, 6Clinical Research Advisor, Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden 7 Senior Lecturer, School of Health, Care and Welfare, Mälardalen University, Västerås, Sweden 8 Senior Lecturer, Institute of Health and Caring Sciences, University of Gothenburg, Gothenburg, Sweden

Keywords clinical pathways, evidence-based practice, implementation, intensive care, organization, standardized care plans Correspondence Mrs Petronella Bjurling-Sjöberg Intensive Care Unit Mälar Hospital Eskilstuna 631 88 Sweden E-mail: [email protected] Accepted for publication:12 November 2014 doi:10.1111/jep.12301

Abstract Rationale, aims and objectives Clinical pathways (CPs) can improve quality of care on intensive care units (ICUs), but are infrequently utilized and of varying quality. Knowledge regarding factors that facilitate versus hinder successful implementation of CPs is insufficient and a better understanding of the activities and individuals involved is needed. The aim of this study was to explore the implementation process of CPs within the context of ICUs. Methods An exploratory design with a sequential mixed method was used. A CP survey, including all Swedish ICUs, was used to collect quantitative data from ICUs using CPs (n = 15) and interviews with key informants (n = 10) were used to collect qualitative data from the same ICUs. Descriptive statistics and qualitative content analysis were used, and the quantitative and qualitative findings were integrated. Results The CP implementation was conceptualized according to two interplaying themes: a process to realize the usefulness of CPs and create new habits; and a necessity of enthusiasm, support and time. Multiple factors affected the process and those factors were organized in six main categories and 14 subcategories. Conclusions Bottom-up initiatives, interprofessional project groups and small ICUs seem to enhance successful implementation of CPs while inadequate electronic health record systems, insufficient support and time constrains can be barriers. Support regarding the whole implementation process from centralized units at the local hospitals, as well as cooperation between ICUs and national guidance, has the potential to raise the quality of CPs and benefit the progress of CP implementation.

Introduction There are concerns that the best evidence is not always applied in clinical practice, leading to suboptimal care for patients [1]. Clinical pathways (CPs), also known as care pathways, critical pathways, etc. [2–4], is a methodology to support quality improvement and integration of evidence into local organizations [5]. While the terminology, models and utilization of CPs differ between countries, this perspective on protocol-based and patient-centred care is gaining in importance globally [4,6,7]. However, CPs are complex interventions, including interprofessional teamwork, organization/ reorganization of care processes and integration of evidence-based

interventions and outcomes [5]. Complex interventions that involve many individuals and multiple tasks can be problematic to implement. Success depends on the characteristics of the object of implementation and the context, as well as the individuals and activities involved [4,8]. The implementation process of CPs is seldom illuminated, the knowledge about the mechanisms through which CPs work remains insufficient and there is need of further knowledge from different contexts regarding the phenomenon [4,6,9–11]. The complex care of critically ill patients at intensive care units (ICUs), present high demands upon efficiency and interprofessional cooperation [12–14]. In this context, CPs can

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contribute to improved quality of care, increased adherence to best-practice guidelines, decreased time with mechanical ventilation, decreased length of ICU stay and reduced hospital costs [6,15–21]. However, CPs within ICUs are still infrequently utilized, the publications are few, some studies have methodological limitations and the findings are not completely consistent, implying a further need of research [16]. In Sweden, a CP is defined as a care and welfare plan that has been decided upon in advance based on a systematically developed knowledge base, describing recommended health care actions for specific health problems [22]. A recent national survey reveals that many ICUs have plans for implementing CPs but CPs are actually in use at only 20% of the ICUs. Furthermore, the survey reveals that the quality of the CPs in use vary, with great differences regarding the content and extension as well as the degree to which the CPs are interprofessional, evidence-based and renewed, which leads to concerns regarding the implementation process [23]. As high-quality CPs may enhance evidence-based practice, a further progress within ICUs has the potential to benefit both patients and health care providers [16]. Then again, the suitability of standardized care at ICUs can be limited because of a heterogeneous patient population and frequent occurring co-morbidities [16,24]. Until now, knowledge regarding factors that facilitate versus hinder a successful implementation of CPs within intensive care is insufficient and a further understanding of the activities and individuals involved in the process is needed [4,23]. The collective experience of key persons from ICUs that are using CPs may enhance the knowledge and understanding of the implementation process and thereby facilitate future CP projects.

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Participants and data collection The ICUs that were using CPs (n = 17) were identified from a national survey that included all Swedish ICUs and were completed 2012 [23]. Two of the 17 eligible ICUs with CPs were excluded since the respondent had not answered the implementation process questions, resulting in a sample of 15 ICUs in the quantitative part of the study (Table 1). The survey questionnaire consisted of 31 questions, whereof 13 concerned the implementation process and were utilized in the present study. The questions largely allowed for multiple responses and were accompanied by a space for comments. Information about the qualitative part of the study and request to interview one key person was sent by email to the 15 ICUs included in the quantitative part of the study. At 10 ICUs, a key person consented to participate (Table 1). The interviewees were all female RNs who had worked at the ICU at the time of CP implementation and all but one had taken an active part in the implementation process. A semi-structured interview guide was developed based on a literature review and the authors’ experiences. It was tested in two pilot interviews, discussed at a seminar and found to be appropriate. The interviews were carried out over the telephone in 2012. The initial question was ‘Can you please tell me about how you started to use CPs?’ The interviews then continued in the form of a dialogue, to cover the areas, origin of the idea, development and introduction activities, use of CPs, climate of change and managers’ roles. In order to capture the interviewees’ experiences and perceptions, the probe questions, sequence and wording varied in accordance with their answers. All interviews were audio recorded and transcribed verbatim.

Aim The aim of the present study was to explore the implementation process of CPs within the context of intensive care.

Methods Design In this exploratory study, a sequential mixed method was used [25]. Given the complexity of CPs and ICUs, a research design based on a combination of quantitative and qualitative methods was appropriate [26]. First, a quantitative approach was used to gain general information of the implementation process. Second, a qualitative approach was used to gain insight into how those committed to the implementation of CPs experienced the process. Finally, the quantitative and qualitative data were integrated to provide a comprehensive understanding of the phenomenon.

Setting Swedish ICUs that were using CPs provided the study setting. Swedish health care is largely publicly funded with local selfgovernance regarding the organization of care [27]. Intensive care is provided at 84 ICUs [28]. The ICU staff includes physicians, registered nurses (RNs), assistant nurses (ANs) and physiotherapists. Physicians from clinics are involved in the patient’s care but are not posted at the ICU. Other health care professionals are available as consultants [29]. 256

Data analysis Data from the survey questionnaire were processed to generate descriptive statistics, using SPSS Statistics (IBM SPSS 19.0.0 IBM Corp., Armonk, NY, USA). The interviews were analysed using qualitative content analysis [30]. The analysis process included five coherent steps. First, each transcription in native Swedish was read to such that the researchers became immersed in the data. Second, meaning units were identified, condensed, abstracted and labelled with codes. Third, codes from all interviews were compared and grouped into categories that were labelled in English. Fourth, the categories were compared and organized into main and subcategories that described the content of the data. Fifth, through reflective discussions in the research group, the underlying meaning of the categories was interpreted and two themes emerged. Throughout the analysis process, constant comparisons took place, involving re-reading, re-sorting and re-labelling, until a satisfying understanding of the interviews was reached. Finally, the quantitative findings were integrated with the qualitative findings to enable further interpretations about the implementation process.

Ethics Ethical considerations followed the Swedish Act concerning the ethical review of research involving humans [31]. Participation was voluntary and data were handled and stored to ensure confi-

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Table 1 Characteristics of participating ICUs, designation of the participants representing the ICUs, history of CPs and current number of CPs at the units ICUs Survey (n = 15) Health care region Northern regions* Southern regions† Category of hospital University hospital County hospital Local hospital Type of ICU General Specialized Size of ICU 1–5 beds 6–10 beds ≥11 beds Participant representing the ICU Head of the department RN coordinating development/education/ documentation RN without special assignment Years with CPs at the ICU Range (median) Current number of CPs at the ICU‡ 1 2 ≥3 Documentation of the CPs Paper-based Included in electronic health record Project group that implemented the CPs RNs and physicians (or also ANs/PTs) RNs and ANs (or solely RNs) First CP implementation Successful Not successful Most recent CP implementation Successful Not successful

Interviews (n = 10)

5 10

3 7

5 6 4

4 5 1

12 3

7 3

5 8 2

1 7 2

6 5

1 9

4



1–12 (4)

1–12 (3,5)

were used with all intended patients, five stated that their CPs usually were used and one that their CPs were used seldom. Multiple interplaying factors affected the implementation process. Based on the interviews, the factors were organized in six main categories and 14 subcategories that described the content of the quantitative data as well as the qualitative data. By further interpretation of the underlying meaning of the categories, two overarching themes emerged (Fig. 1).

Source of inspiration Motives for implementing CPs were most commonly grounded in a wish to improve and assure quality of care. A further motive was to facilitate or improve documentation. I had worked with CPs before. When I started at the ICU I lacked a document where I could check what to do as an ICU-nurse (interviewee 4). Initiative to implement CPs came from enthusiastic the staff, who was inspired by either previous CP experience or education (bottom-up) or from a central decision by either the hospital board or the department management (top-down). When integrating interviewees’ statements with survey data, it was found that all ICUs with bottom-up initiatives (n = 6), and two of the four ICUs with top-down initiatives, reported success regarding the implementation of the units’ initial CP.

The project group 3 8 4

2 5 3

7 8

5 5

10 5

6 4

12 3

8 2

10 2

6 2

*Including regions North, Uppsala-Örebro and Stockholm-Gotland. † Including regions South-East, West and South. ‡ The CPs varied in scope and extent, including care concerning a specific problem, for example, nutrition; a diagnosis, for example, sepsis; a treatment, for example, thrombolytic therapy; a surgical procedure, for example, cardiac surgery; and the total care of a patient at ICU. AN, assistant nurse; CPs, clinical pathways; ICUs, intensive care units; PT, physiotherapist; RN, registered nurse.

The composition of the project groups included active local clinical health care staff. The survey revealed that all ICUs with interprofessional project groups that included physicians (n = 10), and two out of five ICUs with project groups without physicians, reported success regarding the implementation of the units’ initial CP. The interviewees perceived that an interprofessional project group, and early involvement by staff beyond the project group, assured quality and legitimacy of the CPs, contributed to successful implementation and strengthened sustainability. They also perceived that capability to search for evidence as well as previous CP experiences facilitated the implementation process, while lack of knowledge and experience complicated the process and decreased the quality of the CPs. The group dynamics of the project group that was assigned to implement CPs was important to the implementation process. Enthusiastic and supportive individuals were perceived to be a crucial element. It requires a pretty big commitment. I’ve had good support from my colleagues in the group . . . you think it is interesting and fun, you are passionate about it (interviewee 8).

Available resources dentiality. A returned questionnaire was considered consent for the survey and informed consent to be interviewed was given in writing as well as orally.

Results Most CP implementations were perceived as successful (Table 1). Respondents from nine of the 15 ICUs estimated that eligible CPs

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Sufficient allotted time was perceived as crucial. Many interviewees expressed that the creation of CPs took more time than they expected. Cohesive and regularly allotted time was perceived to improve efficiency, especially with respect to the timeconsuming systematic search for evidence. It’s not something you can just sit down and do in half an hour [search articles] . . . you should be given a week to just 257

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Figure 1 Model of the implementation process of clinical pathways (CPs), from the perspective of key persons committed to the CP implementation at their ICUs. Boxes indicate categories, with subcategories, of factors that were perceived to affect the process. Ovals indicate overall themes for how the process was conceptualized.

sit, then you are committed to the way of thinking too. If you get three hours one month and four the next month, there will be no continuity (interviewee 2). In addition, allotted time was beneficial to enabling a structured and pedagogic education of the staff, follow-up, evaluation and renewal of CPs. Time constraints prolonged the process, delayed renewal and further progress and forced prioritization whether developing new CPs or revising old ones. Support from management and colleagues were perceived as crucial throughout the implementation process. Lack of support from managers and physicians created despondency in the project group and undermined the legitimacy of the CPs. Disagreements between disciplines and lack of managers with postgraduate education were perceived as barriers. On the other hand, demonstrated effects of CPs and an interest at a national level were perceived as motivating managers to be supportive. The interviewees called for guidance and cooperation in the implementation process. Several interviewees had a centralized unit that facilitated the creation of CPs at their hospitals. However, they perceived a lack of guidance regarding the introduction of CPs in clinical practice. Some interviewees lacked a centralized CP unit and although some ICUs brought in external consultants, they felt lonely in their struggle to implement CPs. Cooperation between ICUs and national guidance were called for in order to enhance the quality of the CPs and to save resources. When integrating interviewees’ statements with survey data it was found that five out of six ICUs with a centralized CP unit, and three out of four ICUs without a centralized CP unit, reported success regarding the implementation of the units’ initial CP.

Characteristics of the CP Content and scope of the CPs were perceived as affecting implementation. Heterogeneous and complex patient populations at the ICUs complicated the CPs. Qualified nursing and medical care was perceived to place specific demands on interprofessional content. CPs for patients with infrequent diagnoses or treatment regimens were perceived as being more utilized than CPs for patients with more common problems or conditions. On the other hand, CPs that had daily relevance were perceived as facilitating their use. 258

The format of the CPs was perceived as being crucial for acceptance and usefulness. Formats that were not user-friendly created resistance, while comprehensible and familiar formats and terminology facilitated acceptance. The interviewees perceived that paper-based CPs were sometimes sidelined and insufficient electronic health records (EHR) led to lack of compliance. You don’t want to go back to paper, but then you have to adapt the CPs to the computer and that’s not how it should be (interviewee 5). The survey revealed that all ICUs with paper-based documentation of CPs (n = 7) and five out eight ICUs with CPs included in the EHR reported success regarding the implementation of the units’ initial CP.

Implementation activities Several implementation activities were reported. According to the survey, between two and eight activities were used when implementation had succeeded and in unsuccessful implementations, between one and five activities had been used. Education and information in different forms were perceived as crucial for the CP implementation. According to the survey, all 15 ICUs educated staff when implementing their initial CP. Ten of those practiced repeated training and three units used written information. Based on the interviews, mandatory formal interprofessional training, customized to the level of knowledge among the staff, was beneficial. In addition, brief multifaceted and repeated information, for all professionals in as many forums as possible, facilitated implementation. You have to give a lot of information before starting up, so that everyone feels comfortable with it . . . both why and how to use it (interviewee 6). The interviewees emphasized that rapid advancements are taking place in ICUs, accompanied by a supply of new information. Thus, the timing of CP implementation was important to avoid an overall burden of excessive information. Facilitation of the staff’s ability to engage in the CPs was perceived as crucial. Practical support, enforcement guidelines, quick reference guides and an easily available knowledge base were perceived to facilitate the implementation. According to the survey, 11 and three ICUs, respectively, used internal facilitators

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and externals facilitator in the implementation of the units first CP. Repeated reminders were utilized by 14 of the 15 ICUs. Based on the interviews, repeated reminders were crucial to the incorporation of CPs into daily habits and having several people who supported implementation was perceived as beneficial. Feedback and evaluation on a regular basis was perceived as beneficial while lack of evaluation caused uncertainty regarding compliance. A strategy that were perceived as useful for avoiding resistance was to introduce the CPs on a trial basis and then evaluate advantages and disadvantages. In the survey, 12 of the15 ICUs reported that feedback was given after implementation of their initial CP and 10 out of those reported that periodic feedback was given. The CPs were evaluated by regularly or occasionally views from the staff at seven and four ICUs, respectively, by regularly or occasionally review of health records at five and five ICUs, respectively, and by occasional views from patients or relatives at two and two ICUs, respectively.

Characteristics of the staff Change aptitude was perceived as differing between individuals and over time. Large ICUs, with a large staff, were perceived to complicate changes. The survey revealed that all small ICUs (n = 5), six of the eight medium size ICUs and one of the two large ICUs, reported success regarding the implementation of the units first CP. To achieve change, it was perceived crucial that staff realized the benefits and the aims of CPs. Motivational benefits of using the CPs included the definition of steps to be followed; feeling safe in the knowledge that the patients’ care was quality controlled; help in staying abreast through the knowledge base; improved efficiency; and easier documentation. Furthermore, staff’s awareness of a problem (e.g. how many patients suffered from falls when implementing a fall prevention CP) or the need for new knowledge (e.g. when introducing a new treatment) were factors perceived to facilitate a successful implementation. However, old habits were perceived difficult to alter. Forgetfulness and resistance obstructed implementation but these barriers could be overcome with sufficient time and exposure to the new routines. Previous experience and knowledge of documentation and care planning among staff were perceived as facilitating the CP implementation. Lack of familiarity with the way of working complicated implementation and caused resistance. It’s hard. Mainly I think it’s because we have no culture of writing care plans here (interviewee 4). Interviewees from ICUs with several CPs felt that the implementation of later CPs was easier since the staff was familiar with the method.

Usefulness and habit – enthusiasm, support and time Based on the above categories, the CP implementation was conceptualized according to two overarching and interplaying themes: a process to realize the usefulness and create new habits; and a necessity of enthusiasm, support and time. The themes related to each other in both directions all the way through the implementation process. The process originated with an individual or a group who had realized the usefulness of CPs and were enthusiastic enough to initiate the implementation. Next, the process continued

© 2015 John Wiley & Sons, Ltd.

CP implementation at Swedish ICUs

as project groups, managers and staff also realized the usefulness of CPs and over the course of time habits of using the CPs were created. This process required enthusiasm and support among all involved and in all directions. Enthusiasm and support emerged as those involved realized the usefulness of CPs and as managers realized the usefulness time was allotted for the implementation.

Discussion The CP implementation was conceptualized as a process directed at realizing the usefulness and creating habits. This process required enthusiasm, support and time. Complex interventions can be challenging to implement within the interprofessional context of ICUs [16,32], as was confirmed in the present study. Although most implementations were considered successful, the findings were consistent with current literature [1,8], suggesting that the process may be affected by multiple interplaying factors. For the staff to realize the usefulness of CPs, the CPs needed to be user-friendly and have perceived benefits for the staff as well as patients. The findings indicate that bottom-up initiatives were more likely to succeed than top-down initiatives. This is consistent with the consolidated conclusions of current implementation theories, which consider the importance of users realizing the change advantages; that the benefits are readily observable; and that the change is based on credible evidence [8]. Multifaceted strategies are often regarded as more successful than one-dimensional strategies [1,8]. The ICUs in the present study used several activities in order to implement their CPs. Education, information and facilitation was perceived as useful tools. Insufficient EHR was perceived as a barrier and the ICU context, with complex patient populations and large staff, complicated change. Repeated reminders were perceived crucial for altering old habits. The importance of habit is not to be underestimated when trying to implement new work practices, cf. [33]. The CP implementation was dependent on committed individuals who showed great enthusiasm throughout the process and interprofessional project groups were beneficial. All ICUs with interprofessional project groups, including physicians and RNs, reported successful implementation but notably one-third of the ICUs had project groups without physicians. The lack of physician involvement is unfortunate since it is well known that interprofessional project groups enhance the likelihood of successful implementation [34]. Possible reasons for the lack of involvement of physicians in the CP implementations might be staff shortages and/or a skeptical attitude towards CPs because of a fear of losing control over decision making [32]. However, to expand the understanding of this, further research from an interprofessional perspective is needed. Support for the project group, as well as the staff, was perceived as important throughout the process. The importance of guidance, facilitators and leadership are also noted elsewhere [8,34]. Local project groups should include persons who are able to appraise scientific literature [1]. The quality of CPs within ICUs [23], as well as in other settings in Sweden [35], varies and there are significant differences between the ICUs in the southern and northern regions regarding the use of CPs [23]. The present findings indicate a lack of national guidance and insufficient CP support at the local hospitals regarding the implementation. A further national guidance and cooperation would probably enhance the 259

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progress of CPs within the country. Many interviewees felt lonely in their struggle and perceived insufficient support from their managers. Managers’ roles in the implementation of evidence-based practice tend to be passive and limited because of competing demands [36]. The present findings indicate that this may also be the case in the implementation of CPs. Lack of managers with postgraduate education was perceived as a barrier. Postgraduate education enhances awareness of the importance of evidence [37] and might thereby promote CPs as a priority. The creation of a CP, the search for evidence, introducing it into clinical practice, evaluation and renewal were perceived as time consuming, and ample time was necessary throughout the implementation process. Hence, time constraints were barriers to progress. It was also emphasized that the rapid advancements in ICU care had consequences for the timing of the implementation. Resistance to change could be overcome over time if the staff were given a longer period of time in which to become familiar and comfortable with the new routine. Allotting adequate time must be considered when planning a CP project and necessary resources must be given to the task, cf. [32]. The effect of a CP has to be evaluated within the specific context [4]. The ICUs in the present study evaluated their CPs mainly by views from the staff, more seldom by review of health record and only occasionally by views from patients and relatives. This implies that the actual effect of the CPs sometimes were uncertain, which may jeopardize the quality improvement process that is the aim of the CP implementation. In order to achieve improved progress in the implementation of CPs, the mentioned factors must be dealt with. Despite the fact that many implementation theories exist, cf. [1,8,38], none of the interviewees referred to a theoretical framework. A further awareness and utilization of existing frameworks would probably support project groups as well as managers, and thereby facilitate the CP implementation, cf. [8,39].

Methodological considerations A limitation of the present study was the small dataset, which made wider statistical analyses inappropriate. The study was delimited to ICUs that had implemented at least one CP. Each ICU was represented by one person and the participants were mainly RNs committed to CP implementation, which has to be considered when interpreting the findings since staff and managers perspectives can be different. Further, data collection was retrospective, and as such, involved the risk of recall bias. However, the mixed methods enhanced credibility and to achieve trustworthiness validation strategies were applied, as suggested by Lincoln and Guba [40]. Of the 17 ICUs using CPs, quantitative and qualitative data were provided by 88% and 59% of the ICUs, respectively. The participants represented ICUs with different characteristics, which promoted maximum diversity in the sample. The first author’s experiences from intensive care and CPs enabled sensibility to the subject matter. Reflective discussions within the research team, an audit trail of the analysis and translated quotes from the interviews promoted dependability and confirmability. Furthermore, the context and the research process were described, enabling the reader to determine the trustworthiness and transferability of the findings. 260

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Conclusions, clinical implications and further research The present findings indicate that the implementation of CPs within the context of intensive care is a process directed at realizing the usefulness and creating new habits. The process requires enthusiasm, support and time. Multiple factors may affect the CP implementation. The complexity of ICU patients may complicate the implementation. Bottom-up initiatives, interprofessional project groups and small ICUs seem to enhance successful implementation while inadequate EHR systems, insufficient support and time constraints may be barriers. Most implementations were perceived as successful. However, the evaluations of implemented CPs were sometimes insufficient. Further efforts should be taken to evaluate implemented CPs and develop the EHRs to adequately support CPs. Centralized units at the local hospitals that can provide support regarding the whole CP implementation process, as well as cooperation between ICUs and national guidance has the potential to increase the quality of CPs, and benefit the progress of CP implementation. Encouraging bottom-up initiatives and involving physicians to a greater extent might facilitate the implementation process. However, further research is needed to illuminate staff perspective and to expand the understanding of interprofessional interactions and roles of leadership in the implementation process of CP within the context of ICUs.

Acknowledgements We hereby thank the participants who shared their experiences. Funding was provided by Centre for Clinical Research Sörmland, Uppsala University, Sweden.

Author contributions All authors designed the study. PBS and IJ developed the survey questionnaire and the interview guide. PBS managed data collection and transcription, PBS and UP statistical analyses, PBS and IJ primary qualitative content analysis. All authors discussed and interpreted the findings. PBS drafted the manuscript with support from all other authors and all authors approved the final manuscript.

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Factors affecting the implementation process of clinical pathways: a mixed method study within the context of Swedish intensive care.

Clinical pathways (CPs) can improve quality of care on intensive care units (ICUs), but are infrequently utilized and of varying quality. Knowledge re...
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